I-STAT1 ANALYZER, IMMUNO READY 03P75-58

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-06 for I-STAT1 ANALYZER, IMMUNO READY 03P75-58 manufactured by Abbott Point Of Care.

MAUDE Entry Details

Report Number2245578-2019-00262
MDR Report Key9283905
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-06
Date of Report2019-11-06
Date of Event2019-10-31
Date Mfgr Received2019-10-31
Device Manufacturer Date2018-06-14
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA MACZUSZENKO
Manufacturer Street400 COLLEGE ROAD
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6136885949
Manufacturer G1FLEXTRONICS MANUFACTURING (SINGAPORE)
Manufacturer StreetPTE LTD 1 KALLANG PLACE
Manufacturer City339211
Manufacturer CountrySN
Manufacturer Postal Code339211
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameI-STAT1 ANALYZER, IMMUNO READY
Generic NameI-STAT1 ANALYZER
Product CodeCGA
Date Received2019-11-06
Model NumberNA
Catalog Number03P75-58
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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